HSD Compliance Updates

Inquiries and Complaints

New guidance has been posted to help researchers and their staff members understand their role in resolving "research inquiries." "Research Inquiries" include complaints and concerns about the research, the researcher or others voiced to the researcher by a subject, subject's family, or any other source.

Out-of-Window study visits: Reporting to the IRB is no longer required

Our policy about reporting these events has been revised. "Out-of-window" study visits do not necessarily require reporting to the IRB even though these events may meet the definition of non-compliance with approved study procedures. They should be reported only when:

The IRB has required the reporting of all non-compliance for a particular study due to the risks the study poses to subjects, or

The out-of-window visit results in harm to subjects, or

The sponsor requires a report to the IRB.

The decision to discourage routine reporting of out-of-window visits was based on a review of our 2011 compliance data showing that reporting these events did not result in changes to the research or research procedures nor did they present risk to subjects. In addition, most out-of-window study visits were out of the researcher's control so these events seldom met the required reporting criteria. The revised guidance is in Section 4.1.2 of this document: http://www.washington.edu/research/hsd/docs/1218

WIRB Fee Schedule Change: Effective 6/1/2012

All services provided on or after June 1, 2012, will be billed at the new rates.

Contact WIRB's Client Services Department at 360-252-2500 or 1-800-562-4789 if you have any questions.

Presidential Commission for the Study of Bioethical Issues

Request for public comment

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical issues raised by the ready availability of large-scale human genome sequence data, with regard to privacy and data access and the balancing of individual and societal interests.

The deadline for comments is May 25, 2012. See the Bioethics Commission Web site and Federal Register Notice at: http://bioethics.gov/cms/node/676 for more information on how to comment, and on which specific issues.

New and Revised Documents

You may have noticed that HSD has been releasing new or revised written policy, procedure, and guidance documents at a brisk pace during the past year. This is a major effort that will continue during the coming year, due to:

Campus requests

HSD's goal of increasing transparency and knowledge about the IRB review process

The increased frequency of federal regulatory changes

We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We hope you like our new format for presenting the information, and we welcome feedback and suggestions. (hsdforms@uw.edu)

Topic

Research Inquiries

Document(s)

NEW Research Inquiries Guidance for Researchers

Description

Describes the roles of researchers and their staff in helping to resolve inquires from study subjects

Expected impact

Medium - will clarify what constitutes a reportable inquiry, and the timeframe for reporting

Quick Tips from HSD

Welcome to Quick Tips, a new eNews feature that reveals the true meaning of some of those confusing IRB terms!

Exempt?

Exempt is another one of those terms that has a different meaning in connection with human subjects research than you might expect. (Recall how "expedited" doesn't mean quicker in the IRB world.)

It is often thought that "exempt" means that the research activity does not involve human subjects. This is not the case. Exempt, in regulatory speak, means that the activity involves human subjects, however, because it is no more than minimal risk and fits into one or more of the six specific categories of research defined by the federal Office of Human Research Protections or OHRP (affectionately pronounced "O-Harp") it is "exempt from the regulations." An exempt determination is a specific determination that is made only by the Human Subjects Division (HSD). Take a look at either the regulations themselves, or HSD's well written and easy to read Exempt Status Request Guidance document to learn more about the six categories.

While you're reading that guidance, Quick Tips is going to consult the Exempt Magic Eight Ball to clear up some misconceptions about Exempt Research:

Can I use deception in Exempt research, as long as the risk is minimal and I debrief the participants afterwards?

"My reply is no." Deception studies that intentionally provide misleading or false information are not eligible for Exempt status. One example: Participants complete a quiz and are falsely told that they did poorly, regardless of performance.

Does a determination of "Exempt" mean that I have IRB approval?

"Outlook not so good." Exemption is a determination by the staff of HSD that the research is exempt from review by the IRB. However, keep in mind that researchers still have a responsibility to protect the rights and welfare of their subjects, and are expected to conduct their research in accordance with ethical principles, as well as state and local institutional policy.

Exempt means it's not Human Subjects Research, right?

"My sources say no." If a research project involves humans (see the definition of a human subject on the HSD website) it is still human subjects research, even if it is minimal risk, and falls under one of the six categories of exemption.

I've heard that I can determine whether my research is exempt.

"Don't count on it." The staff of the Human Subjects Division are the only individuals authorized at the UW to determine whether the research activity is exempt from federal regulations. The UW applies the federal regulations and guidance about exemption to all human subjects research, regardless of funding, or funding source.

So, if my research is "exempt," I don't have to do anything?

"Very doubtful." You must complete the form "Initial Application: Exempt Status Request" either in Word or PDF. Then, send it to the HSD office to request a determination of "Exempt." Think of "Exempt" as a status that is determined by HSD, according to the specific federal regulations governing human subjects protections. The everyday usage of the word exempt does not really apply.

Hmm, the Exempt Magic Eight Ball is on a negative streak today. Let's refrain from asking it about the lottery.

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